CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Depression Clinical Trial

Official title: CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms

Status Recruiting

Clinical Trial Summary

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Clinical Trial Description

This study is a prospective two-arm, randomized single blind controlled trial design to compare the clinical effectiveness of telemedicine-delivered cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia. A cohort of n=360 adults with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia will be randomized to receive either telemedicine-delivered CBT-I or MBTI. Consistent with previous scientific literature, the interventions will be standardized and six sessions in length. All participants will wear an actigraph wrist monitor throughout the course of the project. All participants will also complete electronic sleep diaries throughout the course of the project. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, ambulatory EEG sleep monitoring) at baseline, at the end of treatment, and at 6- and 12-weeks post-treatment (12- and 24-weeks post randomization, respectively). The primary outcome is insomnia severity (ISI) and secondary outcomes are pre-sleep arousal, and depressive symptoms (PSAS; PHQ-8). Exploratory analyses will include neurocognitive functioning (ANAM) and pre-sleep arousal (PSAS).

Specific Aims are as follows:

Specific Aim 1: Compare telehealth-delivered CBT-I and MBTI in ameliorating insomnia and depressive symptoms among active-duty military personnel with mild to moderate TBI and comorbid insomnia.

Primary Hypothesis 1: MBTI will be non-inferior to CBT-I in reducing insomnia symptoms, as measured by the Insomnia Severity Index (ISI), at the end of treatment and at 6- and 12-weeks posttreatment (i.e., 12- and 24-weeks post-randomization).

Hypothesis 2: MBTI will be non-inferior to CBT-I in reducing depressive (as measured by the Patient Health Questionnaire-8 Item [PHQ-8]) symptoms at the end of treatment, and at 6- and 12-weeks posttreatment (i.e., 12- and 24-weeks post-randomization).

Specific Aim 2: Compare telehealth-delivered CBT-I and MBTI on insomnia severity and pre-sleep arousal in the subset of persons with TBI and comorbid insomnia who also have clinically elevated symptoms of posttraumatic stress.

Co-Primary Hypothesis 3: In the subset of persons with TBI AND clinically elevated PTSS (as defined by PTSD Checklist for Diagnostic and Statistical Manual-5 (DSM-5) score > 31) at baseline, MBTI will reduce insomnia symptom severity (i.e., ISI) significantly more than CBT-I at the end of treatment, and at 6- and 12-weeks post-treatment (i.e., 12- and 24-weeks post-randomization).

Hypothesis 4: In the subset of persons with TBI AND clinically elevated PTSS (as defined by PTSD Checklist for DSM-5 score > 31) at baseline, MBTI will reduce pre-sleep arousal (as measured by the Pre-sleep Arousal Scale [PSAS]), significantly more than CBT-I at the end of treatment, and at 6- and 12-weeks post-treatment (i.e., 12- and 24-weeks post-randomization).

Exploratory Aim 3: Explore mechanisms of telehealth CBT-I and MBTI on sleep and neurocognitive functioning in active-duty military personnel with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia.

Hypothesis 5: In the subset of persons with TBI AND clinically elevated PTSS (as defined by PTSD Checklist for DSM-5 score > 31) at baseline, improvements in sleep (i.e., ISI) will vary as a function of degree of improvement in pre-sleep arousal (as measured by the Pre-sleep Arousal Scale).

Hypothesis 6: The investigators hypothesize that improvements in neurocognitive functioning (i.e., attention, processing speed, working memory, memory, executive functioning), as measured by neuropsychological testing, will vary as a function of degree of improvement in sleep. ;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Mild
• Cognitive Behavioral Therapy
• Concussion, Brain
• Craniocerebral Trauma
• Depression
• Head Injury
• Insomnia
• Memory Impairment
• Post-traumatic Stress
• Sleep
• Sleep Initiation and Maintenance Disorders
• Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT05663034
• Study type: Interventional
• Source: Johns Hopkins University
• Contact: Luis Buenaver, PHD
• Phone: 4105507986
• Email: lbuenav1@jhmi.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2024
• Completion date: September 2026